Purpose of the study:The purpose of this study is to evaluate the effect of cool dialysate on the sleep quality and post dialysis fatigue in patients undergoing hemodialysis in the hospitals of Mashhad. Method: This single blinded clinical trial was conducted on two independent groups. Sixty participants from Imam Reza, Montaserieh, Hevdahe Shahrivar hemodialysis units were recruited through convenience or a non-probability sampling. Then the participants were divided into two groups: a control and an experimental group. Inclusion criteria of study is having some degrees of sleep disturbance and fatigue, having a hemoglobin level >8md/dl. exclusion criteria of study include having an incidence of hemodynamic complications during the intervention sessions; and kidney transplantation. The control group received a dialysis treatment with dialysiate at 37°C and experimental group received a hemodialysis treatment with diaysiate at 35°C, the intervention were carried out for 4 weeks. The data were collected through the self-report PFS and PSQI standard questionnaires at the end of each week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030432862N1
Registration date:2017-08-13, 1396/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Fatemeh Salahshourniat
Name of organization / entity
Mashhad University of Medical Sciences-Nursing&midwifery univercity
Country
Iran (Islamic Republic of)
Phone
+98 51 3521 3615
Email address
salahshournf1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-06-07, 1396/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of cool dialysate on the sleep quality and post dialysis fatigue degree in patient undergoing hemodialysis
Public title
The effect of cool dialysate on the sleep and fatigue in patient undergoing hemodialysis treatments
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having a written consent for participation in the study; being between the age of 18-70; having some degrees of sleep disturbance and fatigue based on the questionnaire; undergoing a dialysis treatment twice or three times a week; undergoing a hemodialysis treatment for at least 6 months; having no experience of participating in similar research; having a hemoglobin level >10md/dl; having no history of crisis in the last 6 months; having no history of mental disease such as major depression; having no history of using depressants; having no history of active cancer; and severe infection.
Exclusion criteria: having an incidence of severe crisis; being diagnosed with incurable diseases such as cancer; kidney transplantation at the time of the study; having no incidence of hemodynamic complications during the most of dialysis sessions; unwillingness to continue participating in the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University Of Medical Sciences
Street address
Qureishi building, Daneshgah street, Mashhad,Khorasan razavi province
City
Mashhad
Postal code
00985138591511
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.MUMS.REC.1395.490
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, stage 5
ICD-10 code
n.18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Sleep quality and post dialysis fatigue
Timepoint
once before the study,3 times during intervention and 1 after ending the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Doining dialysis with 35 ° C dialysate in experimental group
Category
Prevention
2
Description
Doing dialysis with 37 ° C dialysate in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Safavi-Zohreh
Street address
Ebn sina -street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology of Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi mohsen
Street address
Ghoreyshi Building, Daneshgah Stresst
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salahshourniat Fathemeh
Position
Nurse
Other areas of specialty/work
Street address
Hemodialysis unit, Imam reza hospital, Ebne sina street
City
Mashhad
Postal code
Phone
+98 51 3623 5102
Fax
Email
salahshournf1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Chamanzari Hamid
Position
MS degree
Other areas of specialty/work
Street address
Nursing and midwfery university, Doctora cross roads, Ebne sina street
City
Mashhad
Postal code
Phone
+98 51 3852 8514
Fax
Email
chamanzarih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salahshourniat Fatemeh
Position
Bachelor of nursing
Other areas of specialty/work
Street address
Dialysis unit, Imam reza hospital, Ebne sina street